YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 563 drug applications between 25 December 2025 and 31 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 95 drug names.
2025/12/25 – 2025/12/31
- New acceptances this week
- 563
- Drugs with new generic filings (by drug name, de-duplicated)
- 95
- Accepted this week, now under review
- 153
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
563filings, 147 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 221 |
| Generic | 147 |
| New drug | 144 |
| Import | 26 |
| Import re-registration | 16 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 364 |
| TCM | 107 |
| Therapeutic biologic | 83 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
| In vitro diagnostic reagent | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
95 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Upadacitinib Sustained-release Tablets | 5 | 5 | 43 |
| 2 | Brexpiprazole Tablets | 5 | 2 | 31 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 4 | 4 | 53 |
| 4 | Acetylcysteine Oral Solution | 4 | 2 | 11 |
| 5 | Fluticasone Propionate Cream | 3 | 2 | 12 |
| 6 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 7 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 8 | Tadalafil Tablets | 3 | 1 | 23 |
| 9 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 10 | 达普司他片 · No verified English name | 3 | 1 | 0 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
320 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 23 | 21 | 0 |
| 2 | AstraZeneca AB | 9 | 6 | 0 |
| 3 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 5 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Novartis Pharma AG | 5 | 4 | 0 |
| 10 | Hunan Jiudian Pharmaceutical Co., Ltd | 5 | 4 | 1 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
215 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/31Import · Class 2.2 | Nipocalimab注射液 · No verified English nameJXSL2500251 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/12/31Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500406 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/12/31Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500405 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/12/31Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500404 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/31Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500403 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/31Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500402 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/31Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500401 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/31Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500400 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/12/31Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500399 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/12/31Import · Class 1 | NIO752注射液 · No verified English nameJXHL2500398 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/12/31Generic · Class 3 | Ferrous Succinate TabletsCYHS2504518 | Shanxi Bao Tai Pharma Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | Cilnidipine TabletsCYHS2504509 | Beijing Foyou Pharma CO.,LTD |
| 2025/12/31Generic · Class 3 | Calcium Dobesilate TabletsCYHS2504508 | Beijing Kang Er Fu Pharma Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2504506 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2504505 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2504499 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2504498 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Jiangxi Ke Lun Pharma Co., Ltd. romanized |
| 2025/12/31Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2504497 | Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | KN5501细胞注射液 · No verified English nameCXSL2501183 | Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | KN5501细胞注射液 · No verified English nameCXSL2501182 | Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | KN5501细胞注射液 · No verified English nameCXSL2501181 | Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | SND002细胞注射液 · No verified English nameCXSL2501177 | Guizhou Sheng Nuo Bio Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | LBP-ShC4 · No verified English nameCXSL2501176 | Shanghai Jun Ji Health Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | LBP-ShC4 · No verified English nameCXSL2501175 | Shanghai Jun Ji Health Technology Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | 注射用ALK202 · No verified English nameCXSL2501174 | Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | 注射用XNW28012 · No verified English nameCXSL2501173 | Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | CG105 CAR-T细胞注射液 · No verified English nameCXSL2501172 | Sai Si Er Qing Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501171 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501170 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2025/12/31New drug · Class 1 | ICG318 CAR-T细胞注射液 · No verified English nameCXSL2501168 | Hangzhou Ai Sai Mian Yi Bio Medical Co., Ltd. romanized |
185 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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